Regulatory Compliance Solutions

  1. Process Development 4/27/2022

    At Kymanox, our biopharmaceutical, medical device, and packaging experts establish and improve manufacturing processes guided by Quality by Design (QbD) principles. Our risk-based approach ensures your processes are efficient, consistent, cost-effective, and meet regulatory requirements for safety and quality.

  2. Contract Packaging: Pharmaceutical Solid Dose Or Generics

    A generic drug must contain the same active ingredients as the original formulation. According to the U.S. Food and Drug Administration (FDA), generic drugs are identical or within an acceptable bioequivalent range to the brand-name counterpart with respect to pharmacokinetic and pharmacodynamic properties.

  3. Quality Auditing 4/27/2022

    The Kymanox Audit Team consists of Certified Auditors and seasoned Subject Matter Experts (SMEs) across a wide variety of disciplines with extensive expertise in preparing your company for regulatory body inspections and performing internal audits, external audits, gap assessments, and due diligence evaluations. We manage and execute CMC, clinical, laboratory, and supply chain audits around the world, including support for Pre-Approval Inspection (PAI) readiness.

  4. High Performance Thermogravimetric Analyzers 4/17/2023

    Explore a line of cost-effective and flexible thermogravimetric analyzers that provides enhancements in every aspect of TGA technology and a new level of user experience.

  5. Technology Transfer 4/28/2022

    At Kymanox, our branded Technology Transfer methodology combines technical project management, sound science and engineering, quality and regulatory expertise, and business acumen to ensure Right First Time execution. Our approach is heavily based on following CGxP documentation best practices and has been honed over a decade of proven past performance.

  6. Combination Products 4/28/2022

    Kymanox provides turnkey services to bring your product from concept to commercialization — and helps keep your product on the market. Kymanox has expertise in injectables (e.g., syringes, mechanical and electromechanical autoinjectors, wearable injectors, dual chamber systems, reconstitution systems), respiratory combination products (e.g., metered dose inhalers, dry powder inhalers, nasal sprays), and in ocular products (e.g., multi-dose containers, single-use injectables).

  7. Palltronic® Flowstar V Integrity Test Instrument 3/10/2022

    Filter integrity testing reaches a whole new level with the Palltronic Flowstar V featuring higher safety margins with a plug-and-play network integration.

  8. Bioproduction Regulatory Consulting Capabilities 12/20/2022

    Learn more about a service that provides regulatory support, validation guidance, internal consultations, and industry organization guidance while your company implements bioproduction solutions.

  9. Compliance And Validation Services For Waters Informatics Solutions 9/20/2022

    We can assist in the development of necessary validation documents, including test protocols, based on current industry thinking and alignment with global regulatory authority expectations.

  10. Pharmacovigilance 5/28/2024

    The quality of your drug safety team is of the highest importance. That’s why you need an experienced and committed partner who commands the regulatory landscape with confidence. Our global and scalable safety solutions are designed to be efficient, affordable, and fully compliant, giving you flexibility and peace of mind in a complex clinical environment.